Periodontal diseases, the diseases of oral cavity, are a group of diseases affecting the tissues surrounding the teeth. Periodontal means “around the teeth” and includes the gums and bone supporting the teeth. Gingivitis is the mildest form of periodontal (gum) disease. Gingivitis is often caused by inadequate oral hygiene, which leads to plaque buildup. As is well known, gingivitis is a general term comprising the inflammation of the gums resulting from various causes, for instance from toxic, bacterial causes, from dyscrasias, from avitaminosis etc., which are supported and promoted by salivary tartar or by other constitutional factors. The other types of periodontal diseases are aggressive periodontitis, chronic periodontitis and periodontitis associated with systemic conditions like HIV, diabetes, malnutrition and immunosuppression.
Other factors that may contribute to gingivitis and/or other types of periodontal diseases include, diabetes, smoking, aging, genetic predisposition, systemic diseases and conditions, stress, inadequate nutrition, puberty, hormonal fluctuations, pregnancy, substance abuse, HIV infection, and certain medication use.
The inflammatory or swollen state is generally concomitant with a high tendency to bleeding, which results from even very low traumatic causes, such as those due to the commonly performed hygienic care of the oral cavity.
The bacteria in dental plaque irritate the gums and cause infection. When the body launches an immune response against these invaders, the gums become inflamed.
People with gingivitis usually experience little or no discomfort. Therefore, it is important to recognize the symptoms, such as gums that are red, swollen or bleed easily.
Periodontal diseases are usually treated with physical means like scaling and root planing and subsequent adjunctive therapy of localized anti-microbials.
The treatments, which are generally recommended for gingivitis, consist in the employment of special toothpastes, of mouthwashes or of liquid solutions for gums to be applied locally. None of the known products show suitable response to give a rapid and definitive solution to the problem of such diseases of paradentium, as they allow to obtain at most a temporary relief from the swollen or inflammatory state and from bleeding, and, in addition, repeated and constant applications of such products are necessary in most cases.
Several approaches to fight periodontal disease have been described in patents and in literature.
U.S. Pat. No. 6,007,795 discloses a method for inhibiting bacteria in the mouth of a patient that includes placing a particle containing a degradable material and an anti-microbial agent in the mouth of the patient. In general, the invention features a method for inhibiting bacteria in the mouth of a patient that includes placing a particle containing a degradable material and an anti-microbial agent into the mouth of a patient. The saliva in the mouth causes the degradable material in the particle to degrade, resulting in the release of the anti-microbial agent in a controlled manner over time. The exterior of the particle is water-stable allowing the particles to be incorporated into, for example, aqueous rinses or pastes without the water in the rinse or paste causing the degradable material to degrade prematurely, prior to use.
U.S. Pat. No. 5,061,106, discloses capsules or microspheres in the tuft holes in which the bristles of a toothbrush are mounted. The capsules or microspheres include a disinfectant or medicant that is released during use. A dye may also be included in the structures. The dye also is released over time to enable the user to become aware of when the contents of the capsules are depleted.
U.S. Pat. No. 5,976,506 discloses oral care products such as toothpastes with an improved sensorially-perceivable cleaning benefit. This is achieved by the inclusion in the oral care products of agglomerates, substantially free from organic and/or inorganic binding agents, whereby the agglomerates are made of at least two, chemically and/or physically different particulate materials of specified particle sizes. The inclusion of materials having a therapeutic benefit on the teeth or gums in the agglomerates such as zinc citrate provides for a further benefit in that this material is slowly released from the agglomerates, thus providing for a delivery of this material over a longer period. Upon use, the gritty-feeling agglomerates will break-down into smaller particles, thus giving the consumer the feeling of initial cleaning and subsequent polishing.
U.S. Pat. No. 4,780,320 discloses a controlled release drug delivery system for placement in the periodontal pocket. The microparticles are prepared by the solvent evaporation process and are between 10 and 500 microns in size. The matrix of the microparticles consists of cellulose acetate, ethylcellulose, polystyrene, polysulfone, polycarbonate and lacticglycolic acid copolymers.
All of these compositions, however, have proven somewhat unsatisfactory. In conventional release systems no precautions are taken in order to localize the delivery system after administration and, furthermore, the contact time in vivo between the system and a particular site is often so short that no advantages are to be expected with respect to, e.g., modifying tissue permeability.
Additionally, herb-based oral compositions for use in the treatment of diseases of oral cavity are known in the art. Moreover, herbs have been used throughout the world for treatment of many conditions and there is evidence that herbal remedies may tend to have less deleterious side effects than synthetic drugs. The term “curcuminoid substance” broadly covers the substances, e.g. curcumin, terahydrocurcumin, bishydrocurcumin, solvent extracts, crude drug, etc., obtained or derived from the plant Curcuma longa (C. longa). C. longa, commonly known as turmeric is a plant belonging to the family Zingiberaceae. It is commonly used as a spice in India. According to the ancient texts and traditional folklore of India, C. longa is also used as a medicine particularly for treating inflammatory disorders, common cold and wound healing. The rhizome and substances derived from the rhizome have been shown to possess anti-microbial, wound-healing, hypolipemic, anti-inflammatory, anti-oxidant and anti-carcinogenic properties.
Compositions, particularly oral compositions containing curcuminoid substance e.g. curcumin as an active ingredient in combination with other components have been reported in the prior art.
For instance, UK Patent Application No. GB 2317339 discloses an oral composition particularly a dentifrice composition that includes a curcuminoid, fluoride ion source as essential components in combination with one or more of an anticalculus agent, an antimicrobial agent or an antiplaque agent along with one or more carrier material which is useful for preventing and treating gingivitis, periodontitis and other diseases. The patent application also cites a prior art in the form of a Japanese Patent Application that discloses adsorbing curcumin onto a polysaccharide or a derivative of polysaccharide, protein or gel, in an oral hygiene composition, to produce a color change according to the pH of the composition as an indicator that the composition has been in mouth for a sufficient amount of time to fulfill the purpose of hygienic cleansing of the oral cavity.
USSR Inventor's Certificate No. 1132945, also cited in the above-mentioned UK Patent Application, discloses incorporating extracts of turmeric or ginger into toothpaste compositions for improved anti-inflammatory effect on tissues of the oral cavity and treatment of certain diseases of the mucous membranes of the oral cavity and marginal periodontitis.
Although the afore cited prior patent/patent applications provide compositions for oral application, these do not address the problems encountered in treating the difficult to treat diseases such as gingivitis and other periodontal diseases where the treatment requires that the composition provides a localized treatment and is resident at the site of application for longer duration. The afore cited prior art related to the compositions using curcuminoid substance suffers from the disadvantage of not providing a localized treatment that is resident for long time for the treatment of gingivitis and other periodontal diseases.
It is therefore desirable to provide a bioadhesive oral composition for the prevention and treatment of periodontal diseases such as gingivitis and periodontitis, and other periodontal diseases, wherein the contact time in vivo between the system and the site is prolonged substantially, thereby making the composition effective.
The present inventors have discovered oral compositions having improved efficacy which fulfills the long felt need for an oral composition which provides the prevention and treatment of periodontal diseases such as gingivitis and periodontitis, and other oral diseases wherein the composition of the present invention is in contact with the site for a prolonged time in order to be more efficacious. The composition of the present invention comprises a curcuminoid such as curcumin or its derivatives, analogues or curcumin extract and crude herb, and other essential excipients for enhancement of organoleptic properties.
It is therefore, an object of the invention to provide a bioadhesive composition for oral application comprising a curcuminoid substance for the prevention and treatment of gingivitis and other periodontal diseases.
Another objective of the invention is to provide a method for the treatment and prevention of gingivitis and other periodontal diseases comprising the oral application of a bioadhesive composition comprising a curcuminoid substance.